Europe

New EudraVigilance system is live for patients across Europe

Monday, November 27, 2017

The EMA has launched a new and improved version of EudraVigilance, the European information system of suspected adverse reactions to medicines that are authorized or being studied in clinical trials in the European Economic Area (EEA). The new system makes it easier for marketing authorization holders and sponsors of clinical trials to report suspected adverse reactions and allows for better analysis of this information for the benefit of patient safety in Europe.

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Cambridge Epigenetix appoints Professor Mark Dawson as Scientific Advisor

Monday, November 27, 2017

Cambridge Epigenetix, a pioneer in the development and application of epigenetic technologies, announced the appointment of epigenetics-based therapeutics specialist Professor Mark Dawson to its Scientific Advisory Board (SAB). Professor Dawson brings a wealth of experience in the translation of cancer epigenetics research to clinical practice. The appointment further strengthens CEGX’s panel of opinion leaders providing expert advice across the Company’s key focus areas of epigenetics, oncology, liquid biopsy, diagnostic and therapeutic development.

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TESARO announces EC approval of ZEJULA for recurrent ovarian cancer

Monday, November 20, 2017

TESARO, an oncology focused biopharmaceutical company, announced that the European Commission (EC) has granted marketing authorization for ZEJULA (niraparib) as a monotherapy for the maintenance treatment of adult patients with platinum-sensitive relapsed high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete response (CR) or partial response (PR) to platinum-based chemotherapy. ZEJULA is the first once-daily, oral poly (ADP-ribose) polymerase (PARP)1/2 inhibitor to be approved in Europe that does not require BRCAmutation or other biomarker testing.

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New EU medical device regulations cause industry shake up

Monday, August 21, 2017

Medical device manufacturers will need to provide substantially more clinical evidence to support claims of safety and performance for many medical and in vitro diagnostic (IVD) devices marketed in the European Union (EU) as the result of two new regulations adopted by the European Parliament.

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